NIH Proposes Critical Initiatives to Sustain Future of Biomedical Research

HS Public Health Emergency Medical Countermeasures Plan

Antibiotic Awareness Week Alert

CMS Announces New Waived Tests and New Molecular Billing Codes

ASM General Meeting Minority Travel Grant

Minority Microbiology Mentor Newsletter

ASM Letter Comments on HPAI H5N1 QuestionsThe ASM Public and Scientific Affairs Board sent a letter December 14 in response to the Centers for Disease Control and Prevention’s (CDC) announcement in the October 17 Federal Register opening a docket for 60 days to obtain information and comments from the public on questions concerning highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. This information will be considered in a determination of whether such viruses should be listed as HHS select agents, by revising the HHS Select Agent Regulations (42 CFR Part 73). The ASM letter said that all highly pathogenic avian influenza viruses are already USDA select agents and the question is whether designating the specific HPAI H5N1 influenza viruses containing the HA gene from the Goose/Guangdong/1/96 lineage an HHS tier 1 agent increases biosafety and biosecurity, i.e., whether it would enhance public health and safety. The ASM letter said that doing so is not warranted at this time. The complete letter is available at http://asm.org/index.php/component/content/article/137-policy/documents/statements-and-testimony/90970-12-14-12-h5n1.

NIH Meeting on HPAI H5N1 Research IssuesThe Department of Health and Human Services (HHS) sponsored an international consultative workshop on December 17-18 at the National Institutes of Health on Gain-of-Function Research on Highly Pathogenic Avian Influenza H5N1 Viruses. The workshop provided a forum for sharing multidisciplinary international perspectives on research that aims to increase transmissibility, increase pathogenicity, and/or alter host range of highly pathogenic avian influenza (HPAI) H5N1 viruses. Dr. Ronald Atlas, cochair of ASM’s Public and Scientific Affairs Board Biodefense Committee, attended the workshop. Specific issues for discussion included the implications of such research for global public health; risks and concerns associated with this research; the risks of not conducting such research; fundamental principles regarding the conduct and oversight of such research; and conditions under which such research might be conducted. Perspectives were presented by individuals from around the globe who collectively have a broad range of expertise in such areas as influenza, other infectious diseases, dual use research, bioethics, national and global public health, biosecurity, epidemiology, national security, public health surveillance, biosafety, biosecurity agriculture/veterinary sciences, the WHO International Health Regulations and the Pandemic Influenza Preparedness Framework, global public health law, and medical countermeasure development. The participants also evaluated a proposed HHS funding framework through discussion of a series of case studies. The proposed HHS funding framework for guiding decisions about HPAI H5N1 gain of function research and case studies are available for review and comment at http://oba.od.nih.gov/biosecurity/internationalwebcast.html. The framework and the dual use research of concern proposal should be finalized in 2013.

ASM Supports R&D Funding During Sequestration DiscussionsASM endorsed a letter written by the Agriculture and Food Research Initiative (AFRI) Coalition and sent to the White House and Congressional Leadership urging them to come to a bipartisan agreement on budget issues of the “fiscal cliff” before the end of the year to avoid cuts to R&D. The letter was sent on December 13 to President Obama; Senate Majority Leader Harry Reid; Senate Minority Leader Mitch McConnell; Speaker John Boehner and Minority Leader Nancy Pelosi. It encouraged Congress and the President to work together to find long term solutions to current fiscal issues without cuts to agricultural R&D funding, specifically the Agriculture and Food Research Initiative (AFRI), the USDA’s competitive grants program. A copy of the letter can be found on the ASM public policy webpage at: http://asm.org/images/PSAB/AFRISequestration-Ltr.pdf

On December 4, ASM staff attended an NDD (non-defense discretionary) Summit meeting on Capitol Hill entitled “Planning for the Plan.” Senator Patty Murray spoke about sequestration negotiations and the importance of preserving R&D programs funded with nondefense discretionary funds. The NDD summit, of which ASM is a member, is a coalition of organizations, societies and academic institutions among others who support nondefense discretionary funding.

ASM is a signatory to a letter co-signed by more than one hundred organizations, scientific societies and universities urging the President and Congress to work together to find a solution to sequestration or the “fiscal cliff” without cuts to science and technology R&D funding. The letter, sent on December 7, warns that sequestration would cut $11.3 billion from the National Institutes of Health (NIH) over the next ten years, $4.6 billion in nondefense R&D from the Department of Energy (DOE) by 2017 and the National Science Foundation (NSF) would lose $2.1 billion over five years. A copy of the full letter can be found at: http://www.asm.org/images/PSAB/Sequestration12-07-2012.pdf

ASM endorsed a letter co-signed by two hundred members of the Ad Hoc Group for Medical Research, voicing grave concern over potential cuts to the NIH as a result of sequestration and asking that Congress and the administration work together to find a solution. The letter stated that sequestration would reduce NIH funding by more than $2.5 billion and would “negatively affect job creation and seriously jeopardize America’s leadership in medical research.” A copy of the letter can be found on the ASM public policy webpage at: http://asm.org/images/PSAB/AHG-Sequestration12-11-12.pdf

ASM Works With OSTPIn November, The President's Council of Advisors on Science and Technology (PCAST) released a report entitled: "Transformation and Opportunity: The Future of the U.S. Research Enterprise." The report calls for an increase in federal funding of science, technology, engineering and mathematics (STEM) education as a way to grow R&D expenditures and warns that without investing more in basic research, the US risks losing its competitive edge to other nations. A copy of the full report can be found at: http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast_future_research_enterprise_20121130.pdf

On December 7, ASM staff attended two meetings at the White House:

The release of the President’s Council of Advisors on Science and Technology (PCAST) report to the President on Agricultural Preparedness & the Agricultural Research Enterprise. John P. Holdren, Ph.D., Assistant to the President for Science and Technology, Director, Office of Science and Technology (OSTP) and Catherine Woteki, Ph.D., Chief Scientist & Undersecretary for Research, Education and Economics (REE) at the Department of Agriculture attended and presented the report which calls for a stronger investment in federal funding for competitive grants at the USDA. A copy of the full report can be found at: http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast_agriculture_20121207.pdf

A meeting with staff from the Office of Science and Technology Policy (OSTP), on sequestration or the “fiscal cliff.” Bess Evans, Public Engagement Advisor and Policy Analyst in the Offices of Science and Technology Policy and Public Engagement and John P. Holdren, Ph.D., Assistant to the President for Science and Technology, Director, Office of Science and Technology, spoke to the group and discussed ways to avoid further cuts to nondefense discretionary and R&DASM continues to work closely with OSTP and updated information can be found on public policy webpage at: http://www.asm.org/index.php/public-policy2/126-whats-new-in-public-policy/whats-new-in-policy/7470-radfy2013

In December, ASM staff participated in three conference calls with the White House regarding sequestration or the “fiscal cliff”:

On December 5, ASM staff participated in a call entitled: “Science and Technology Stakeholder Call on the Fiscal Cliff and Sequestration” with John P. Holdren, Ph.D., Assistant to the President for Science and Technology, Director, Office of Science and Technology (OSTP) and Jon Carson, Director of the Office of Public Engagement. Discussed were updates on the sequestration negotiations and potential impacts to science, technology, innovation and STEM education funding.

On December 11, ASM staff participated in a call with senior administration officials and the White House Business Council who discussed the president’s plan for the FY 2013 budget and sequestration.

On December 18, ASM staff and the Coalition for Health Funding participated in a conference call with Jon Carson, Director of the Office of Public Engagement and discussed sequestration updates, end of year actions, and plans for potential future

Meetings on Agriculture ResearchOn November 29, ASM attended the second organizational meeting of the Supporters of Agricultural Research (SOAR) coalition in Washington DC. Discussed were issues including, membership recruitment, communications plans and strategies for future involvement with the federal agencies, congress and the administration. The group’s mission statement was confirmed as: “SOAR is committed to educate the general public and the Congress about the importance of competitively federally funded agricultural research and to increase funding of AFRI in support of such research.” As a founding member, ASM staff will continue to work closely with the coalition. More information can be found on the SOAR website at: http://supportagresearch.org/soar-for-science/

In December, ASM and the AFRI Coalition met with staff in House leadership offices to discuss the importance of a Farm Bill and especially its research title. ASM and the AFRI Coalition met with staff in the offices of: Representative Eric Cantor, Majority Leader; Representative Collin Peterson, Ranking Member, House Committee on Agriculture; Representative Greg Walden and Representative Kevin McCarthy. The 2008 Farm Bill expired in September 2012 and without an extension or new bill, US farm policy covered under the law will revert to the Agricultural Act of 1949, the last permanent Farm Bill signed into law.

IOM Forum on Emerging DiseasesIn its 1992 report, Emerging Infections: Microbial Threats to Health in the United States, the Institute of Medicine (IOM) pointed to major challenges for the public health and medical care communities in detecting and managing infectious disease outbreaks and monitoring the prevalence of endemic diseases. The recommendations of this report addressed both the recognition of and interventions against emerging infections. The IOM created the Forum on Emerging Infections (now the Forum on Microbial Threats) in 1996 at the urging of the Centers for Disease Control and Prevention and the National Institutes of Allergy and Infectious Diseases, as a follow–on activity to the findings and recommendations of the Emerging Infections report. The ASM is a member and sponsor of the Forum on Microbial Threats which was created to provide a structured opportunity for stakeholder discussion and scrutiny of critical--and possibly contentious--scientific and policy issues of shared concern related to basic and applied research on the detection, surveillance, prevention, and management of naturally-occurring, reemerging, and novel communicable diseases in humans, plants and animals.

An Anniversary Symposium, attended by ASM leadership, was held on December 11 to look back at the 1992 (Emerging Infections) and 2003 (Microbial Threats to Health) reports; review and assess the progress made on these reports’ recommendations; and reflect on the creation of the Forum in 1996. Among the topics discussed were: Where are we (as a community and as a forum) now versus 20 years ago?; what progress has been made in the surveillance, detection and responses to emerging, reemerging and novel infectious diseases in humans, plants, and animals; and how our appreciation of the microbiome and microbial ecology has changed in the 20 years since the publication of the IOM’s Emerging Infections report.

ASM Signs Clinical Laboratory Coalition Letter to House LeadersOn November 30, ASM joined with 49 members of the Clinical Laboratory Coalition, representing America’s community, regional, hospital-based, and national clinical laboratories in a letter to House leadership. The letter requests protection of access to Medicare Part B clinical laboratory services as Congress works to address end of year fiscal matters, including sequestration and the pending Medicare SGR cuts to physicians. The letter specifically urges legislators to oppose any additional reductions in the Medicare Part B Clinical Laboratory Fee Schedule, which was cut by Congress earlier this year. Further reductions to the fee schedule, whether through a direct cut or the imposition of new laboratory cost sharing requirements, threaten laboratory providers’ ability to serve their communities and specifically meet the needs of the Medicare population. The letter can be found here http://asm.org/images/PSAB/CLC-11-29-12.pdf

ASM Staff Attend Meet with CDC Board of Scientific CounselorsASM participated in the Dec 5 meeting of the Centers for Disease Control and Prevention (CDC) Board of Scientific Counselors, Office of Infectious Diseases. The day-long Atlanta meeting covered six separate topics in detail, including addressing increasing numbers of pertussis cases, implementing new recommendations for reducing HCV morbidity and mortality, the CDC response to the fungal meningitis outbreak, and a report from the Antimicrobial Resistance Working Group. Speaking at the board meeting were CDC Director Thomas Frieden, Rima Khabbaz, CDC Deputy Director for Infectious Diseases, and Beth Bell, the director of the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID). This full board meets twice a year. For more information about it, including its charter and roster, see http://www.cdc.gov/oid/BSC.html.

TEST Act Signed into LawS. 3391, Taking Essential Steps for Testing Act of 2012, whichpassed the Senate by unanimous vote November 13, was signed by the President on December 4, making it Public Law No: 112-202. To read the text, see http://www.gpo.gov/fdsys/pkg/BILLS-112s3391rs/pdf/BILLS-112s3391rs.pdf. This bill amends the Public health Service Act to revise sanctions for laboratories that refer proficiency testing (PT) samples to another laboratory for analysis. Previously, the Department of Health and Human Services (HHS) could only revoke the certification of lab referring PT samples for one year and impose a two-year lab-operating moratorium on owners and operators of those labs. This change in the language allows the HHS Secretary some flexibility in the sanctions that can be used in these cases.

National Select Agents Registry Makes Documents AvailableThe National Select Agents Registry has made guidance documents for Final Rule compliance assistance available on their website. Users will be able to select from a list of documents to assist in complying with the requirements of the Select Agents regulations by going to this site http://www.selectagents.gov/Guidance_Documents.html. A Webcast from their November 16 detailed 2012 Select Agent Workshop training is available at that same page. This day long training included precise instructions on how to fill out forms, so viewing it may be beneficial to all laboratory personnel who possess any of the Tier 1 select agents.

ASM Attends December CCCLW MeetingOn December 10, Vickie Baselski represented ASM at the Coordinating Council for the Clinical Laboratory Workforce (CCCLW) Meeting in Chicago, IL. The CCCLW is a coalition of organizations interested in working together to ensure a high quality clinical laboratory workforce. There was a review of the CCCLW’s strategic plan and in particular, priorities for 2013-2014. Specifically, coalition members discussed how CCCLW efforts could help to retain an adequate number of qualified practitioners for the laboratory workforce. Additionally, CCCLW members discussed content for the launch of the newly recreated CCCLW website.

NIH Proposes Critical Initiatives to Sustain Future of Biomedical ResearchThe National Institutes of Health is seeking to launch multiple initiatives designed to help strengthen the biomedical research enterprise and sustain the global competitiveness of the U.S. scientific community well into the future. Faced with significant challenges affecting the biomedical research workforce and the storage and use of large biomedical datasets, the NIH Director charged the Advisory Committee to the Director (ACD) to develop recommendations. The ACD used three specialized committee working groups, each of which included additional outside experts on the relevant topics.

The ACD presented its recommendations to the NIH director in June 2012. NIH leadership further deliberated on the recommendations and presented its implementation plan at the 105th meeting of the ACD on Dec. 6 and 7. The actions that NIH is seeking to implement are:

Diversity in the Biomedical Research WorkforceThe NIH launched a new program called Building Infrastructure Leading to Diversity (BUILD) intended to provide rigorous mentored research experiences for undergraduate students at participating schools; financial support to pursue biomedical research careers; faculty support for training highly effective mentors; and innovation space to develop new approaches for increasing diversity in the Ph.D. training pathway. The program:

Establishes a National Research Mentoring Network to connect students, postdoctoral fellows, and faculty with experienced mentors; develop standards of good mentorship in biomedical research; and provide workshops and training opportunities in grantsmanship, among other goals.

Promotes fairness in peer review through interventions including implicit bias and diversity awareness training for both scientific review officers and members of review panels, and piloting a program that would make grant applications completely anonymous.

Increase engagement of NIH leadership by:

recruiting a chief diversity officer to coordinate NIH initiatives designed to enhance the diversity of the NIH-funded workforce

establishing an NIH steering committee working group on diversity to help ensure that diversity remains a core consideration of NIH governance

The Future Biomedical Research WorkforceDevelop a model for a sustainable and diverse U.S. biomedical research workforce that can inform decisions about training of the optimal number of people for the appropriate types of positions that will advance science and promote health. Developing the model will include an analysis of the current composition and size of the workforce to understand the consequences of current funding policies on the research framework.

Enhance training of graduate students and postdoctoral researchers:

through a grants program that would support innovative approaches to complement traditional research training

by encouraging the adoption of individual development plans for all trainees

Increase emphasis on ongoing assessment of the biomedical research workforce, including a proposed follow-up study on clinician scientists.

Identify and track more comprehensively all graduate students and postdoctoral researchers supported by NIH to provide a sound basis for assessing workforce needs and planning future training activities. More comprehensive career outcomes data also would help to inform prospective graduate students and postdoctoral researchers contemplating careers in biomedical research.

Data and InformaticsIn response to the incredible growth of large biomedical datasets, the Director of NIH has charged the Advisory Committee to the Director (ACD) to form a special Data and Informatics Working Group (DIWG).

Maximize the value of biomedical data through a new Big Data to Knowledge (BD2K) initiative that would create:

improved data and software sharing policies, catalogs of research data, and data/metadata standards development to facilitate broader use of biomedical big data

analysis methods and software development and dissemination

enhanced training for biomedical big data

proposed new centers of excellence

Launch the NIH InfrastructurePlus adaptive environment to advance high-performance computing, agile hosting and storage approaches, and modernization of the network, among other approaches.

HHS Public Health Emergency Medical Countermeasures PlanThe 2012 Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan was release in December. This plan describes the priority activities and programs that HHS, in collaboration with its interagency partners, will implement over the next five years to advance the strategic goals and underlying objectives established in the 2012 HHS PHEMCE Strategy, published earlier this year. Together, the 2012 HHS PHEMCE Strategy and Implementation Plan provide the blueprint for the PHEMCE to enhance national health security through the procurement and effective use of critical medical countermeasures.

The 2012 HHS PHEMCE Strategy and Implementation Plan is designed to rapidly produce and effectively use medical countermeasures in the face of any emergency public health incident or attack, from known or unknown threats.The 2012 HHS PHEMCE Implementation Plan can be found online, along with the 2012 PHEMCE Strategy, at http://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx. Antibiotic Awareness Week AlertThe ASM sent an alert to members regarding Antibiotic Awareness Week (November 11 – 17). Last year the ASM was one of the first societies to support the Antibiotic Action initiative of the British Society of Antimicrobial Chemotherapy. This initiative is now 12 months old and is raising awareness of the need for new antibiotics. ASM members can sign an online petition for Antibiotic Action to demonstrate the need for new antibiotics. This petition is being used to encourage policy makers to support antibacterial drug discovery, research and development. To sign the petition, go to Antibiotic Action website at: http://antibiotic-action.com/. To see ASM’s statements and activities related to antimicrobial resistance go to: http://asm.org/index.php?option=com_content&view=article&id=2637.

CMS Announces New Waived Tests and New Molecular Billing CodesOn Oct 1, The Centers for Medicare and Medicaid Services (CMS) updated the list of Clinical Laboratory Improvements Act (CLIA) waived tests. The updated list includes eleven new FDA approved waived tests; they include tests for Influenza A+B, Strep A, and Borrelia burgdorferi and Helicobacter pylori antibodies. As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” To see the updated list of waived tests, please go to http://www.cms.gov/Regulations-and-guidance/Guidance/transmittals/downloads/R2496CP.pdf.

On October 16, CMS published Revisions to Payment Policies under the Physician Fee Schedule. This comprehensive revision places some 115 newly created molecular pathology Current Procedural Terminology (CPT) codes under the Clinical Laboratory Fee Schedule (CLFS) for 2012-2013. In addition, a new code, G0452, has been set aside for use when physician interpretation of a molecular pathology procedure is medically necessary. This G code has been designated as an interim code on the Physicians Fee Schedule (PFS) and will be monitored by CMS throughout calendar year 2013. There is no corresponding code for interpretation by a doctoral level scientist or other appropriately trained nonphysician health care professional on either the CLFS or the PFS since they do not have a Medicare benefit category that allows them to bill and be paid for their interpretation services. To see the revisions in their entirety, please see https://www.federalregister.gov/articles/2012/11/16/2012-26900/revisions-to-payment-policies-under-the-physician-fee-schedule-dme-face-to-face-encounters.

ASM General Meeting Minority Travel GrantIn an effort to increase the participation of underrepresented minority (URM) groups in microbiology related fields, ASM will offer American General Meeting Minority Travel Grants to help defray expenses associated with travel to asm2013. Postdoctoral scholars, faculty from URM groups, and faculty from Minority Serving Institutions and Community Colleges who have demonstrated their interest in mentoring URM trainees in the microbiological sciences will be eligible to receive up to $2,000. Funding for this program is pending. For complete details on eligibility requirements, selection criteria, and to download the application form, please visit http://www.asm.org/asmgmminoritytravelgrant.